This high accuracy 21CFR-compliant
standalone data logger measures more than 16,000 readings over a -35 to
+80°C (-31 to +176°F) and 0 to 100% relative humidity (RH) range. At
the touch of a button, use the on-board display to cycle between the
current, minimum and maximum logs seen during the session for both
temperature and humidity.
WHAT IS 21 CFR PART 11?
Normally when using environmental
recorders consisting of hardware, sensors and software, the data is
collected and stored in various means. To comply with 21 CFR Part11
the entire data processing has to be validated to make sure that
there is no data corruption through the entire process.
21 CFR Part 11 is confirming the
instruments information / data digital signature. To ensure that data
generated by a software and/or recording devices have not been
voluntarily or involuntarily altered/modified. It details several
points that a organizations must implement before stating its solution is 21 CFR Part 11
compliant by generating a PDF file that cannot be modified, certify
that data are encrypted, software must have an ID and password to
login, audit trail and the instrumented and sensors are
This standard is usually known and
requested in the life science industry. If you want to rely on
loggers to certify that pharmaceutical products are correctly
maintained within their proper range of temperature, you have to make
sure that data generated is reliable.
The purpose of 21 CFR part 11 is
basically to ensure that the data read and stored by a software and
environmental instruments are entirely accurate.